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ACTIVE NOT RECRUITING
NCT04524273
PHASE3

Myasthenia Gravis Inebilizumab Trial

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2020-10-15

Completion Date

2027-11-29

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

inebilizumab

Participants will receive IV inebilizumab

DRUG

IV Placebo

Participants will receive IV placebo matched to inebilizumab

Locations (104)

Viela Bio Investigative Site - 1015

Orange, California, United States

Viela Bio Investigative Site - 1002

New Haven, Connecticut, United States

Viela Bio Investigative Center - 1024

Washington D.C., District of Columbia, United States

Viela Bio Investigative Site - 1005

Tampa, Florida, United States

Viela Bio Investigative Site - 1012

Kansas City, Kansas, United States

Viela Bio Investigative Site - 1018

Charlotte, North Carolina, United States

Viela Bio Investigative Site - 1025

Canton, Ohio, United States

Viela Bio Investigative Site - 1001

Cincinnati, Ohio, United States

Viela Bio Investigative Site - 1009

Columbus, Ohio, United States

Viela Bio Investigative Site - 1008

Pittsburgh, Pennsylvania, United States

Viela Bio Investigative Site - 1019

Austin, Texas, United States

Viela Bio Investigative Site - 1003

Houston, Texas, United States

Viela Bio Investigative Site - 1014

San Antonio, Texas, United States

Viela Bio Investigative Site - 1017

Salt Lake City, Utah, United States

Viela Bio Investigative Site - 1004

Burlington, Vermont, United States

Viela Bio Investigative Site - 1006

Richmond, Virginia, United States

Viela Bio Investigative Site - 2001

Buenos Aires, Argentina

VielaBio Investigative Site - 2002

Buenos Aires, Argentina

Viela Bio Investigative Site - 2003

Buenos Aires, Argentina

Viela Bio Investigative Site - 5203

Grodno, Belarus

Viela Bio Investigative Site - 5204

Minsk, Belarus

Viela Bio Investigative Site - 5201

Vitebsk, Belarus

VielaBio Investigative Site - 2201

Porto Alegre, Brazil

VielaBio Investigative Site - 2203

Porto Alegre, Brazil

VielaBio Investigative Site - 2207

Ribeirão Preto, Brazil

VielaBio Investigative Site - 2206

São Paulo, Brazil

Viela Bio Investigative Site - 2205

São Paulo, Brazil

Viela Bio Investigative Site - 1102

Toronto, Ontario, Canada

Viela Bio Investigative Site - 1101

Montreal, Quebec, Canada

Viela Bio Investigative Site - 1103

Montreal, Quebec, Canada

Viela Bio Investigative Site 4009

Beijing, China

Viela Bio Investigative Site - 4007

Beijing, China

Viela Bio Investigative Site 4003

Beijing, China

Viela Bio Investigative Site - 4005

Guiyang, China

Viela Bio Investigative site 4010

Hunan, China

Viela Bio Investigative Site - 4011

Jinan, China

Viela Bio Investigative Site - 4006

Shanghai, China

Viela Bio Investigative Site - 4008

Suzhou, China

Viela Bio Investigative Site - 4004

Tianjin, China

Viela Bio Investigative Site 4012

Xi'an, China

Viela Bio Investigative Site - 5601

Copenhagen, Denmark

Viela Bio Investigative Site - 3003

Lille, France

Viela Bio Investigative Site - 3001

Nice, France

Viela Bio Investigative Site - 3002

Strasbourg, France

VielaBio Investigative Site - 3101

Essen, Germany

Viela Bio Investigative Site - 4107

Nagpur, Maharashtra, India

Viela Bio Investigative Site - 4113

Nagpur, Maharashtra, India

Viela Bio Investigative Site - 4112

Hyderabad, Telangana, India

Viela Bio Investigative Site - 4104

Bangalore, India

Viela Bio investigative Site - 4105

Lucknow, India

Viela Bio Investigative Site - 4103

Manipal, India

Viela Bio Investigative Site - 4102

Nashik, India

Viela Bio Investigative Site - 4109

Pune, India

Viela Bio Investigative Site - 4101

Surat, India

Viela Bio Investigative Site - 3204

Milan, Italy

Viela Bio Investigative Site - 3203

Milan, Italy

Viela Bio Investigative Site - 3201

Pavia, Italy

Viela Bio Investigative Site - 3202

Rome, Italy

Viela Bio Investigative Site - 4402

Chiba, Japan

Viela Bio Investigative Site - 4410

Chiba, Japan

Viela Bio Investigative Site 4409

Fukuoka, Japan

Viela Bio Investigative Site - 4401

Hanamaki, Japan

VielaBio Investigative Site - 4408

Hokkaido, Japan

Viela Bio Investigative Site - 4406

Hyōgo, Japan

Viela Bio Investigative Site 4405

Miyagi, Japan

Viela Bio Investigative Site - 4413

Moriguchi, Japan

VielaBio Investigative Site - 4407

Morioka, Japan

Viela Bio Investigative Site - 4404

Saitama, Japan

Viela Bio Investigative Site - 3302

Katowice, Poland

Viela Bio Investigative Site - 3303

Katowice, Poland

Viela Bio Investigative Site - 3301

Krakow, Poland

Med Polonia Sp. z o.o - 3311

Poznan, Poland

Viela Bio Investigative Site - 3310

Warsaw, Poland

Viela Bio Investigative Site - 5313

Barnaul, Altayskiy Kray, Russia

Viela Bio Investigative Site - 5303

Barnaul, Russia

Viela Bio Investigative Site - 5302

Nizhny Novgorod, Russia

Viela Bio Investigative Site - 5304

Novosibirsk, Russia

Viela Bio Investigative Site - 5311

Rostov-on-Don, Russia

Viela Bio Investigative Site - 5309

Rostov-on-Don, Russia

Viela Bio Investigative Site - 5308

Saint Petersburg, Russia

Viela Bio Investigative Site - 5305

Samara, Russia

Viela Bio Investigative Site - 5312

Ufa, Russia

Viela Bio Investigative Site - 4202

Seoul, South Korea

Viela Bio Investigative Site - 4203

Seoul, South Korea

Viela Bio Investigative Site - 4201

Seoul, South Korea

Viela Bio Investigative Site - 3403

Badalona, Spain

Viela Bio Investigative Site - 3402

Barcelona, Spain

Viela Bio Investigative Site - 3404

Córdoba, Spain

Viela Bio investigative Site - 4605

Kaohsiung City, Taiwan

Viela Bio Investigative Site 4608

New Taipei City, Taiwan

Viela Bio Investigative Site - 4606

Tainan, Taiwan

Viela Bio Investigative Site - 4604

Taipei, Taiwan

Viela Bio Investigative Site - 4603

Taipei, Taiwan

Viela Bio Investigative Site -4607

Taipei, Taiwan

Viela Bio Investigative Site - 4602

Taoyuan, Taiwan

Viela Bio Investigative Site - 3903

Ankara, Turkey (Türkiye)

Viela Bio Investigative Site - 3901

Izmir, Turkey (Türkiye)

Viela Bio Investigative Site - 3902

Izmir, Turkey (Türkiye)

Viela Bio Investigative Site - 3905

Kocaeli, Turkey (Türkiye)

Viela Bio Investigative Site - 5103

Dnipro, Ukraine

Viela Bio Investigative Site - 5108

Dnipro, Ukraine

Viela Bio Investigative Site - 5105

Ivano-Frankivsk, Ukraine

Viela Bio Investigative Site - 5104

Lutsk, Ukraine

Viela Bio Investigative Site - 5106

Vinnytsia, Ukraine